N/A
N=72
Ocular Comfort and the "Aging" Lens (ERBIUM)
Refractive Error
Bottom Line
View on ClinicalTrials.gov: NCT01198600 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 1 — 76; 88 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Habitual contact lens (Device); Lotrafilcon B contact lens (Device); Contact lens cleaning and disinfecting system (ClearCare) (Device)
- Age
- Pediatric, Adult, Older Adult · 17+ yrs
- Sex
- All
- Sponsor
- CIBA VISION
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 1 |
76; 88 | — |
| PRIMARY Phase 3: Ocular Comfort, Lens Age 1 Day, Hour 10 |
69; 76 | — |
| PRIMARY Phase 3: Ocular Comfort, Lens Age 1 Day, End of Day |
65; 67 | — |
| PRIMARY Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 1 |
80; 79 | — |
| PRIMARY Phase 3: Ocular Comfort, Lens Age 14 Days, Hour 10 |
77; 64 | — |
| PRIMARY Phase 3: Ocular Comfort, Lens Age 14 Days, End of Day |
72; 60 | — |
| PRIMARY Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 1 |
78; 74 | — |
| PRIMARY Phase 3: Ocular Comfort, Lens Age 27 Days, Hour 10 |
72; 63 | — |
| PRIMARY Phase 3: Ocular Comfort, Lens Age 27 Days, End of Day |
66; 57 | — |
Summary
The purpose of this trial was to evaluate the factors affecting comfortable contact lens wear and how those factors affect contact lens replacement frequency.
Eligibility Criteria
Inclusion Criteria
- At least 17 years of age.
- Ocular exam in the last two years.
- Currently wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis with a monthly replacement schedule.
- Wearing contact lenses at least five days per week for a minimum of 10 hours each day.
- Able to wear lenses in the available power range with a best-corrected visual acuity of at least 20/32 in both eyes.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Any ocular disease.
- Systemic condition that may affect a study outcome.
- Using any systemic or topical medications that may affect ocular health.
- Wears lenses on an extended or continuous wear schedule.
- Habitually wears multifocal lenses.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01198600). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.